Surgical access instruments for use with delicate tissues

ABSTRACT

One or more surgical instruments provide access to delicate tissue, such as brain tissue or breast tissue, through a transcutaneous incision, for a variety of reasons, such as to access a surgical site for providing a working channel for accessing delicate tissue by surgical instruments, to provide access to insert an inflatable prosthesis, or for providing an external buttress channel for supporting tissue thereon. The surgical instrument assembly includes an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer. The wedge introducer is introduced into an area adjacent to the hollow sleeve. The distal tip of the wedge introducer extends beyond a distal end of the hollow retractor, forward of a distal end of the hollow retractor, so that the wedge introducer traverses delicate tissue ahead of the distal end of the hollow retractor, guiding the hollow retractor into place to the delicate tissue.

FIELD OF INVENTION

This disclosure relates to surgical access instruments for use withdelicate tissues and methods of use.

BACKGROUND

Traditional surgical brain retractors are thin, firm bands of steel orother metal alloys, with abrupt or well-defined edges and have limitedsurface areas. The common structural form is a simple strip of sheetmetal consisting of a metal strip which can be bent by hand and thesurface of which typically is clearly outlined on the brain after a fewminutes. Particularly noticeable are the pressure marks of the lateralspatula edges which indicate a high local compression stress. Thesetraditional retractors can be introduced into the tissue of the brain oralong brain surfaces, and then pulled with force to either separate orelevate the brain tissue during surgery. This method allows the targetarea to be illuminated and visualized in order to perform the surgicalprocedure. However, brain tissue is quite soft and delicate,particularly after trauma, loss of blood supply, or in the presence ofbrain edema. The brain tissue is a gel-like substance that can be easilydamaged, and a complication known as “retraction injury” can occur,sometimes resulting in compromised brain function. The brain tissues canbe torn by the relatively sharp edges of these retractors, and/or theretracted brain can loose blood supply when the local pressure beneaththe retractor is greater than venous pressure. The result can beischemic changes in the underlying brain and/or the more seriouscomplication of venous brain infarction.

The combination factors including the softness of the brain tissue, andthe effects of sharp, blunt edges and limited surface area oftraditional metal band retractor also results in limited visualizationof the surgical target area. The brain tends to extend beyond or “droop”around the edges of the retractor, limiting the area necessary forlighting and reducing overall visibility.

Furthermore, the amount of local pressure exerted by the retractor onthe brain tissue must be limited to avoid injury, which may impede thesurgeon's ability to safely gain enough visualization area. Oftentimes,the surgeon will resort to the strategy of exposing far more of thebrain tissue than is necessary or desirable to open the area around thebrain widely enough so as to limit the amount of local retractionpressure. This method is undesirable, as compared to a less invasiveapproach, for both the patient and surgeon.

It would be advantageous to provide a surgical instrument assembly thatsafely addresses the short comings of the presently-known instruments.

OBJECTS OF THE INVENTION

The objects and design principles of the surgical access instrumentassemblies of this invention are as follows:

(1) to maximize surface area of the retractor, so as to distributepressure evenly and minimize effective local retraction pressure;

(2) to enable integration with stereotactic neuro-navigation computerguidance system;

(3) to reduce the need to “pull” on a brain retractor, to obviate thepossibility of accidental over-retraction and thereby avoid braindamage;

(4) to allow for binocular vision with the utilization of ellipticalarchitecture;

(5) to allow for maximal lighting access clearance a target tissuevisualization;

(6) to allow for minimization of brain disruption by limiting thecorticotmy via use of a small elliptical window for the transcorticalintroducer;

(7) to allow for minimization of brain disruption with the utilizationof tapered forward edges;

(8) to enable stable retraction fixation to avoid accidental retractordisplacement;

(9) to provide retractors which are of lightweight materials to allowfor ease of manipulation; and/or,

(10) to provide transparent retractors to allow for direct visualizationof underlying brain tissue.

Other objects which become apparent from the following description ofthe present invention.

SUMMARY OF THE INVENTION

In keeping with these objects and others which may become apparent, thepresent invention is directed toward an access assembly for surgicalinstruments. The access assembly for surgical instruments includes twoprincipal components. One component is an internal instrument accessassembly and the other is an external instrument access assembly. Theinternal instrument access assembly is designed to enter the brain togain access to deeper internal brain structures. The external instrumentaccess assembly is designed to elevate the surfaces of the brain to gainaccess to external structures along, around or beneath the brain. Bothwill be produced in varying sizes according to the needs of individualoperations. The materials for these retractors will be composed oftransparent biocompatible lightweight plastic. Each of the instrumentassemblies include two separate parts, a retractor that also functionsas a working channel, and a compatible introducer.

The internal instrument assembly is a wedge retractor introducer, whichpreferably includes a hollow wedge formed by all or part of a closedcurve in cross section, such as an elliptical rounded wedge or an archshaped wedge. It includes a hollow brain access working channel that canbe fixed in space to a standard neurosurgical fixation cable device.First, a protruding introducer element, having a length greater than thelength of the hollow working channel, is introduced into the workingchannel. Its distal smooth and relatively soft tapered end works tospread apart the brain hemispheres or other portions of delicate braintissue. When the working channel is introduced, the introducer isremoved, leaving the hollow working channel for the surgeon to access tothe target tissues. Variations will include length (Z axis), and widthand height (X and Y axes) of the elliptical working channel andintroducer.

A fixation portion is designed to be attached to a standardneurosurgical armature fixation device.

The external surgical access instrument assembly is characterized by anarched hemi-elliptical architecture, wider along the base (X axis) thantall (Y axis). It is smooth, tapered at the leading edge, has a handlefixation portion that is o the same design as that of the internalinstrument assembly, and is designed to be attached to a standardneurosurgical armature fixation device. Variations will be in length (Zaxis) as well in X and Y axes.

Therefore, the present invention encompasses one or more surgicalinstrument assemblies to provide access to delicate tissue, such asbrain tissue or breast tissue, through a transcutaneous incision, for avariety of reasons, such as to access a surgical site; to provide accessto insert an inflatable prosthesis; or to provide access for providingan external buttress channel for supporting tissue thereon. The surgicalinstrument assembly includes an interleaved combination of an opensleeve hollow retractor and a tapered tipped wedge introducer. The wedgeintroducer is introduced into an area adjacent to the hollow sleeve. Thedistal tip of the wedge introducer extends beyond a distal end of thehollow retractor, forward of a distal end of said hollow retractor, sothat the wedge introducer traverses the delicate tissue ahead of thedistal end of the hollow retractor, guiding the hollow retractor intoplace in the delicate tissue.

When used in conjunction with working surgical instruments, the distalend of the introducer has a small opening, preferably elliptically oval,to allow for removal of small portions of tissue from a surgical site.

The hollow retractor may have a diameter which is a closed curve, suchas an elliptical oval. In such case, a tapered tipped wedge introduceris inserted into the inside of the closed curved hollow retractor. In analternate embodiment, the tapered tipped wedge introducer may have adiameter which is an arc, wherein the arc is a portion of a closedcurve, and further wherein the tapered tipped wedge is an archinsertable into the closed curved hollow retractor.

When used as an external working channel, the distal end of the workingchannel is bell shaped, to allow for increase for increased surface areaexposure.

The hollow retractor may alternatively also be an arc of a portion of aclosed curve, also forming an arch shape. In such case, the taperedcurved tipped wedge introducer may also be an arc of a portion of aclosed curve, also forming an arch shape.

In the case where the hollow retractor and/or the tapered tipped wedgeintroducer has a diameter of at least one arc of a curve, theypreferably can have a decreasing curved cross sectional diameter.

Moreover, in such case where the hollow retractor is arch shaped, asopposed to being a closed curved shape, such as being an-elliptical ovalin cross section, the wedge introducer is placed adjacent to the concaveinner portion of the hollow retractor.

If the hollow retractor is a closed curve, that is, having an ellipticaloval cross section, preferably of decreasing diameter towards it distal,tissue contact edge, then the combination of the hollow retractor andwedge introducer are used to either spread apart adjacent delicatetissues, such as the left and right hemispheres of the brain, or totraverse the delicate tissue, such as brain tissue, to provide internalaccess to a surgical site within the delicate tissue.

If the hollow retractor is arch-shaped, that is, having a diameter whichis an arc, namely, a portion of a closed curve, then the combination ofthe hollow retractor and the wedge introducer are used to provide accessto a delicate tissue, where the delicate tissue is supported upon theconvex outer surface of the hollow retractor, forming a supportbuttress, after removal of the arch-shaped wedge introducer.

Additionally, if the hollow retractor is also arch-shaped, that is,having a diameter which is an arc, namely, a portion of a closed curve,then additionally the combination of the hollow retractor and the wedgeintroducer is used to provide access to a delicate tissue, where aninflatable member, such as a breast prosthesis, is inserted into thedelicate breast tissue and inflated, after removal of the arch-shapedwedge introducer from the hollow arched retractor.

The tipped wedge introducer has an exterior surface corresponding to aninterior surface of the hollow sleeve and the closed end tipped wedgeintroducer may have a diameter with an arc of a decreasing curved crosssection approximating the arc of the curved cross section of the opensleeve of the retractor.

Preferably, the hollow retractor includes a handle attachable to aclamp.

Optionally, the hollow retractor and the tapered tipped wedge introducerinclude a lock temporarily locking said tapered tipped wedge introduceradjacent to the hollow retractor.

When the hollow retractor is elliptically oval in cross section, theclosed plane curve is generated by a point moving in such a way that thesums of its distances from two fixed points is a constant, or the closedplane curve is a plane section of a circular cone that is a notperpendicular to an axis of the cone, thereby forming a planarelliptical oval slice through the cone.

Moreover, the hollow retractor may be flared at a proximal end.Additionally, where a base of a handle is attached, the handle may mergein a cascading shape, interrupting the continuous curve of the proximalend of the hollow retractor. Such a cascading dip in structure allowsfor easier finger access into the working channel of the hollowretractor.

Additionally, the hollow retractor may have a changing cross section,where the cross sectional diameter of the elliptical oval is wider ornarrower at selected regions of the working channel of the hollowretractor.

DESCRIPTION OF THE DRAWINGS

The present invention can best be understood in connection with theaccompanying drawings. It is noted that the invention is not limited tothe precise embodiments shown in drawings, in which:

FIG. 1 is a view of a patient with a retractor assembly and a buttresschannel positioned adjacent to a top of the head and lower skull.

FIG. 2 is a perspective of retractor assembly of FIG. 1.

FIG. 3 shows exploded components of FIG. 2.

FIG. 4 is a top plan view of an introducer.

FIG. 5 is a proximal end view of an introducer.

FIG. 6 is a side sectional elevational view thereof.

FIG. 7 is a top plan sectional view thereof.

FIG. 8 is a sectional detail of a locking tab, taken from FIG. 7.

FIG. 9 is a top plan view thereof.

FIG. 10 is a proximal end view of the retractor.

FIG. 11 is a side sectional elevation thereof.

FIG. 12 is a top plan sectional view thereof.

FIG. 13 is a sectional detail view of the groove, taken from FIG. 12.

FIG. 14 is a sectional detail of locking tab and groove, taken at 14-14of FIG. 2.

FIG. 15 is a proximal end view of the assembly, taken at arrow 15 inFIG. 2.

FIG. 16 is a view of the instrument assembly being inserted into the topof a skull.

FIG. 17 is a view of the instrument assembly spreading the brain lobesapart.

FIG. 18 is a view of the instrument assembly installed, taken at arrows18-18 of FIG. 17, with an ear of introducer flexed.

FIG. 19 is a view of the instrument assembly with the introducerremoved.

FIG. 20 is a view of surgical instruments within the retractor channel.

FIG. 21 is a diagrammatic sectional view of an embodiment which isinstalled transversely into tissue.

FIG. 22 is a view of the external instrument assembly system adjacent tothe lower skull.

FIG. 23 is a view of the instrument assembly components of FIG. 22exploded.

FIG. 24 is a perspective view of the instrument assembly systeminstalled in the lower skull.

FIG. 25 is a diagrammatic side section of installed instrument assembly,with the introducer removed.

FIG. 26 is a diagrammatic view of the instruments working on an externaltumor.

FIG. 27 is a diagrammatic view of an alternative embodiment, installedthrough forehead.

FIG. 28 is a diagrammatic view of the instrument assembly installed intobreast tissue.

FIG. 29 is a perspective exploded view of a surgical kit.

DETAILED DESCRIPTION

This disclosure relates to a surgical instrument assembly and system foruse with delicate tissues and methods of using the instrument assembly.The instruments are designed for use during surgery on delicate tissues,such as brain and breast tissues, although they may be used in anymedical context. The instrument assembly includes several portions, suchas, an introducer portion, a tissue access channel retractor portion(“channel portion”) having at least one handle portion, and a styletteportion. These instrument portions are formed to maximize the surfacearea of the retractor, which distributes pressure approximately equallythough out the surrounding tissues and minimize effective localizedretraction pressure on the tissues in contact or immediately surroundingthe Instrument.

In one embodiment, the surgical instrument assembly can be a retractorin the form of an arch or arc shape, into which an arch or arc shapedwedge introducer may be inserted for surgical access to the externalportions or surfaces of the brain.

In another embodiment, the surgical instrument assembly can be aretractor in the form of a wedge with a tapered elliptical crosssectional shape, into which a tapered elliptical cross sectionalintroducer may be inserted for surgical access to the external portionsor surfaces of the brain.

Alternatively, the external retractor and wedge introducer may be usedto insert medical/cosmetic devices into or under delicate tissues.

The surgical instrument assembly system may also employ the externalretractor as an external brain support buttress channel portion to liftthe brain mass upward with respect to the cranium to provide stabilityand prevent the gelatinous brain materials from shifting during surgery.In the capacity of a brain support buttress channel portion (“buttressportion”) also provides improved visualization and improved access tothe surgical area by lifting the brain matter upward in the cranium.

The formation of the instrument assembly also eliminates the need to“pull” on a retractor portion to clearly visualize the surgical area byinitially providing a sufficient work area via the channel retractor.The use of the tissue access channel retractor portion of the instrumentassembly eliminates or greatly lowers the possibility of accidentalover-retraction. By avoiding excess retraction, damage to thesurrounding tissues is also avoided, including possible brain damage.

While other closed curve configurations may be used, the preferablyelliptical or arch shaped architecture formation of the instrumentassembly portions is such that medical staff is afforded binocularvision, rather than the monocular vision typically found in similardevices. This elliptical architecture also provides far greaterclearance for lighting access to illuminate the target surgical area andallow full visualization of that area. The forward edge of the channelretractor is preferably tapered to gently separate tissue to obtain asurgical area and minimizes disruption of the tissue.

The surgical instrument assembly system may also be useful as aninserter instrument for breast implants.

The dimensions of the surgical Instrument assembly may vary and bemodified according to an intended use. Generally, the surgical workspace formed by the introducer portion 40 can have diameters of in therange of approximately 10 millimeters (“mm”) to approximately 100 mm,and more typically in the range of approximately 25 mm to approximately75 mm in its closed configuration. The open configuration of theintroducer portion 40 may extend the diameter of the distal end 42 ofthe introducer portion 40 several millimeters, and may generally bedetermined by amount of extension desired by the surgical team duringuse as it is introduced into the lumen 22 of the retractor 20, and mayinclude a flexible band portion 14 to enhance its flexibility. The openconfiguration may also be determined by the overall desiredcircumference and diameter of the Surgical Instrument assembly for aparticular use and may be manufactured in a variety of useful sizes tobe available as is practical. The Surgical Instrument assembly may beformed of any biocompatible material which will provide sufficientstability and strength necessary to provide a surgical work area. Thebiocompatible material may be disposable or sterilize-able for repeateduse. In one embodiment, the Surgical Instrument assembly may be formedof a lightweight plastic material for ease of manipulation and/or thematerial may be transparent to allow direct visualization of underlyingbrain tissue thorough the Instrument assembly portions.

The surgical instrument assembly system also enables integration withstereotactic neuro-navigation computer guidance systems to enhancevisualization of the surgical area of the brain.

FIG. 1 illustrates in diagrammatic fashion the surgical instrumentassembly system 10 adjacent a surgical aperture in the cranium of anintubated patient. An external retractor system 100 is also spaced fromthe lower skull, and will be described later in the specification.

FIG. 2 is an enlarged perspective view of the surgical instrumentassembly system 10 as shown in FIG. 1. The instrument assembly system 10is comprised of two components, a retractor 20, and an introducer 40.

FIG. 3 illustrates the relationship of introducer 40 to retractor 20,prior to assembly. It is desirable that the introducer is easily fixedto and removable from the retractor both prior to and during thesurgical procedure.

As also shown in FIG. 3, the surgical instrument assembly system may beformed by any method, including injection molding, as a single piece, ormay be formed of two or more pieces which are permanently fixedlyattached to each other. The distal end 42 of the introducer portion 40is preferably a solid, rounded cone shape which may or may not includean opening 52 to the surrounding tissues as opposed to a cannulastructure which always provides a distal opening. The distal end 42preferably includes a gently increasing circumference 54, whichincreases and expands towards the proximal end 56 of the introducerportion 42. The introducer portion 40 has a main body 50, and may bedivided into two approximate handle halves 46, having V-shaped cutouts48 between the handle halves. The halves of the proximal end 56 are anintegral unit, the term “halves” is used as a descriptor only and doesnot describe separable parts, as opposed to two disassemblable halves.The proximal end 56 may include at least one handle portion 46 whichextends outwardly at an angle of approximately 90 degrees. A handleportion 46 may be useful to allow a medical team member to physicallyinsert, manipulate or hold the handle portion 46, or a conventionalsurgical fixation cable may be attached to the handle portion 12. Atleast one of the handle portions 46 include at least one indentation orgroove 44 to accept or snap into an additional portion of the surgicalinstrument assembly 10.

FIGS. 4-8 show a variety of views of the retractor portion 20 of thisdisclosure, including retractor 20 having a hollow working channel 22and handle 28. The retractor 20 is generally formed to dimensions andshapes to coincide with the introducer portion 40 that may be slidablyinserted into the brain access work channel 22 of the retractor portion20. The retractor portion 20 is generally shorter in length than theintroducer portion 40 to allow the distal end 42 of the introducerportion 40 to interact with the surrounding housing 21 tissues. As bestseen in FIGS. 6 and 7, the retractor portion 20 is formed as a hollowelliptical rounded wedge having a tapered distal leading edge 24. Theproximal edge of the retractor 20 includes a slightly rounded lip 26 anda handle portion 28. At least one tab 30 is formed in wedge 21, justdistal of lip 26. Tab 30 will positively align with groove 44 ofintroducer 40 to prevent or inhibit unnecessary movement or slipping ofthe instrument assembly components best seen in sectional view FIG. 15.The handle portion 28 allows the retractor portion 20 to be fixed inspace with the use of a standard or conventional neurosurgical fixationcable device.

FIG. 9 illustrates a side view of a retractor 20, having a proximal end26 of the surgical instrument assembly and optionally having a handleportion 28 perpendicular to the proximal end 26; and an ellipticallength of the retractor 21 extends to the rounded distal end 24. FIG. 10is a frontal view of the retractor 20, showing the lumen 30 and thehandle portion 28. FIG. 11 is a cross-sectional view of the retractor 20of the rounded shape of the retractor 20 to avoid damage to delicatetissues. FIG. 12 is a top plan view of the retractor 20, emphasizing thegroove like cut-out hole 30 which can allow the introducer 40 tointegrally fit and temporarily lock/snap into hole 30, thereby causingboth the retractor 20 and introducer 50 to function as one, whiledesired by the medical team. FIG. 13 is an enlarged view of the groovedhole 30. FIG. 14 is a cross-sectional view of the tab 44 of theintroducer 20 while it is engaged within the grooved hole 30 of theretractor 20.

Shown in FIG. 15 is a proximal end view of assembled instrument wherethe handle portions 46 overlying lip 26 of retractor 20, and V-shapedcutouts 48 residing in lumen 22. Handle 28 of retractor 20 is moldedintegral with lip 26, providing both rigidity and strength. FIG. 15 alsoshows that where a base of handle 28 is attached to retractor 20, handle28 may optionally merge in a cascading shaped dip 28 a, interrupting thecontinuous curve of the proximal end of hollow retractor 20. Such acascading dip 28 a allows for easier finger access into the workingchannel of hollow retractor 20.

FIGS. 16-20 illustrate diagrammatically the method if installingsurgical instrument assembly 10 into the aperture 12 in cranium 14. Asseen in FIG. 16, instrument assembly 10 is inserted into aperture 12.Distal end 42 of introducer 40 is abutting brain tissue 60. Asinstrument assembly 10 is introduced, distal end 42 of introducer 40begins to spread lobes 62 and 64 of brain 60, as shown in FIG. 17. FIG.18 is an elevational view of the installed surgical instrument assembly10, taken along arrows 18-18 of FIG. 17. Upon installation, handles 46of introducer 40 may be flexed inward, thereby releasing the tab 30 ofretractor 20 from the groove 44 of introducer 40. FIG. 19 illustratesintroducer 40 during removal from lumen 22 of retractor 20. FIG. 20shows surgical instruments 70 within lumen 22 of retractor 20, examiningbrain tissue 60.

FIG. 21 is a diagrammatic perspective view of an embodiment of thesurgical instrument assembly 10, adjacent an aperture 12 located at thetemple region of a patient's cranium 14. In this embodiment, the overalllength of surgical instrument assembly 10 is sufficient to transverselypenetrate the cranium and brain tissue 60. Surgical instrument assembly10 is shown installed in FIG. 22.

FIG. 23 is a perspective view of the external retracting buttresschannel 100. External buttress channel instrument assembly 100 iscomprised of buttress channel component 200, and wedge introducercomponent 400. External buttress channel component 200 has a generallyarched, hemi-elliptical architecture, where it is wider along the basethan it is tall or high. The buttress channel component 200 includes asmooth, tapered leading edge 202. A handle fixation member 204 isapproximately perpendicular to the rounded lip 206 of the proximal end208. The handle member 204 may be employed as an attachment point to astandard neurosurgical armature fixation device. The external buttresschannel component 200 may be used to lift, support or manipulate thebrain within the skull cavity to provide additional or improved visionof the surgical area, as seen in FIG. 24.

Also seen in FIG. 23 is the external wedge introducer portion 400 forthe external buttress channel component 200. Buttress channel 200 isdesigned to gain access to external structures along, around or beneaththe brain by elevating the surfaces of the brain to allow access tosurgical locations on or near the surface of the brain tissues. Inoperation, prior to insertion, introducer portion 400 is attached tobuttress channel 200 such that sloping distal end 402 protrudes from thedistal open end 210 of buttress channel 200. This pushes away braintissue at the outer brain surface 66 gently during insertion. Afterinsertion, introducer portion 400 is withdrawn to leave a workingchannel of decreasing hemi-oval cross section from proximal end 208 todistal end 210. Radial surface of buttress channel 200 supports theouter surface 66 of the brain tissue 60, best seen in FIG. 24. Note thatsurface of wedge introducer 400 conforms to the inside of buttresschannel surface; proximal end 208 and handle member 204 conform toproximal end 406 and fixation member 408 of introducer 400 respectively.Fixation member 204 of buttress channel 200 is designed to be attachedto a standard neurosurgical armature fixation device.

FIGS. 25 and 26 are diagrammatic view of the instruments working on anexternal tumor, where the further surgical instruments 70 are insertingin t0 the operating space formed by the instrument assembly system toallow the surgical team to work on the tissues as necessary.

FIG. 27 is a diagrammatic view of an embodiment, which may be installedthrough the forehead as necessary for surgical procedures. FIG. 28 is adiagrammatic view of the instrument assembly installed into breasttissue 68, where it may be used for insertion of implants 72 and thelike.

FIG. 28 shows use of an arched buttress channel 200 and wedge introducercomponent 400 which may be used, for example, for access to brain tissueor for inserting an inflatable prosthesis into breast tissue.

FIG. 29 is a perspective exploded view of a surgical kit. The Kit 600includes an injection-molded or vacuum-formed housing 602, providingcavities 604 to receive components of the surgical instrument assemblysystem 10 and the external retracting buttress channel system 100. Astylette 80 may also be included. Upon placement of all desiredcomponents within the housing 602, the sterile kit will be sealed with aTyvek sheet 606. Upon removal of sheet 606 by the surgeon, the sterilecomponents of kit 600 can be utilized and employed as required in asurgical operation.

In the foregoing description, certain terms and visual depictions areused to illustrate the preferred embodiment. However, no unnecessarylimitations are to be construed by the terms used or illustrationsdepicted, beyond what is shown in the prior art, since the terms andillustrations are exemplary only, and are not meant to limit the scopeof the present invention.

It is further known that other modifications may be made to the presentinvention, without departing the scope of the invention, as noted in theappended Claims.

1. An apparatus providing access to delicate tissue through a transcutaneous incision comprising: an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer; said wedge introducer being introduced into an area adjacent to said hollow sleeve; a distal tip of said wedge introducer extending beyond a distal end of said hollow retractor, at a location region forward of a distal end of said hollow retractor, so that said wedge introducer traverses the delicate tissue ahead of said distal end of the hollow retractor, guiding said hollow retractor into place to the delicate tissue; and, said tapered tipped wedge introducer being removable from said open sleeve of said hollow retractor adjacent the delicate tissue, leaving the delicate tissue exposed to a said open sleeve of said hollow retractor.
 2. The apparatus providing access into delicate tissue as in claim 1 further comprising: said hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter; said tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter; said tapered tipped wedge introducer retractor having a length exceeding a predetermined length of said hollow retractor, providing an advancing member extending forward of a distal end of said hollow retractor; said tapered tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve; said tapered tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve; said hollow retractor and said tapered tipped wedge introducer being insertable adjacent to the delicate tissue; and, said hollow retractor and said tapered tipped wedge introducer being advanced together to the delicate tissue.
 3. The apparatus as in claim 1 wherein said hollow retractor provides access for at least one surgical instrument to a surgical site within the delicate tissue.
 4. The apparatus for providing access to delicate tissue as in claim 1 wherein the hollow retractor and the interleaved tapered tipped wedge introducer spread a portion of delicate tissue apart from another portion of delicate tissue toward the surgical site.
 5. The apparatus for providing access to delicate tissue as in claim 1 wherein the hollow retractor and the interleaved tapered tipped wedge introducer intersect transversally into a portion of delicate tissue at the surgical site.
 6. The apparatus as in claim 1 wherein said hollow retractor supports the delicate tissue thereupon.
 7. The apparatus as in claim 1 wherein said apparatus provides access for at least one inflatable prosthetic member into the delicate tissue and inflating the inflatable member.
 8. The apparatus as in claim 1 wherein said hollow retractor includes a handle attachable to a clamp.
 9. The apparatus as in claim 1 wherein said hollow retractor and said tapered tipped wedge introducer include a lock temporarily locking said tapered tipped wedge introducer adjacent to said hollow retractor.
 10. The apparatus for providing access to delicate tissue as in claim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is a closed plane curve.
 11. The apparatus for providing access to delicate tissue as in claim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve.
 12. The apparatus as in claim 1 wherein a distal end of said tapered introducer has a small opening at a distal end thereof, allowing for removal of small portions of tissue from a surgical site.
 13. The apparatus for providing access to delicate tissue as in claim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve wherein the closed plane curve is generated by a point moving in such a way that the sums of its distances from two fixed points is a constant.
 14. The apparatus for providing access to delicate tissue as in claim 2 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve wherein the closed plane curve is an elliptical oval-shaped plane section of a circular cone that is a not perpendicular to an axis of the cone.
 15. The apparatus for providing access to delicate tissue as in claim 14 wherein said at least one arc of said curve of said diameter of said hollow retractor is an arc of a portion of a closed plane curve wherein the closed plane curve is an elliptical oval.
 16. The apparatus for providing access to delicate tissue as in claim 2 wherein said arc of said hollow retractor is a portion of a continuous arc.
 17. The apparatus for providing access to delicate tissue as in claim 2 wherein said arc of said hollow retractor is a continuous arc.
 18. The apparatus for providing access to delicate tissue as in claim 2 wherein said arc of said tapered tipped wedge introducer is a portion of a continuous arc.
 19. The apparatus for providing access to delicate tissue as in claim 2 wherein said arc of said tapered tipped wedge introducer is a continuous arc.
 20. The apparatus for providing access to delicate tissue as in claim 2 wherein said closed plane curve is flared outward at a proximal end.
 21. A method of providing access into delicate tissue for at least one surgical instrument assembly comprising the steps: making an incision into delicate tissue; providing a hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter; providing a tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter introducing said tapered tipped wedge introducer into an area adjacent to said hollow sleeve having said at least one arc of a curve having a decreasing curved cross sectional diameter; said closed end tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve; said closed end tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve; placing said hollow retractor and said tapered tipped wedge introducer into the delicate tissue; advancing said hollow retractor and said tapered tipped wedge introducer through said delicate tissue to a surgical site therein; retracting said tapered tipped wedge introducer from said open sleeve of said hollow retractor adjacent the tissue; and, accessing at least one surgical instrument to the surgical site within the delicate tissue.
 22. A method of providing access into delicate tissue for at least one surgical instrument comprising the steps: making an incision into delicate tissue; providing a hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter; providing a tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter introducing said tapered tipped wedge introducer into an area adjacent to said hollow sleeve having said at least one arc of a curve having a decreasing curved cross sectional diameter; said closed end tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve; said closed end tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve; placing said hollow retractor and said tapered tipped wedge introducer into the delicate tissue; advancing said hollow retractor and said tapered tipped wedge introducer through said delicate tissue to a surgical site therein; retracting said tapered tipped wedge introducer from said open sleeve of said hollow retractor adjacent the tissue; and, supporting the delicate tissue thereupon.
 23. A method of providing access into delicate tissue for at least one surgical instrument comprising the steps: making an incision into delicate tissue; providing a hollow retractor having an open sleeve having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter; providing a tapered tipped wedge introducer having a diameter of at least one arc of a curve having a decreasing curved cross sectional diameter introducing said tapered tipped wedge introducer into an area adjacent to said hollow sleeve having said at least one arc of a curve having a decreasing curved cross sectional diameter; said closed end tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve; said closed end tipped wedge introducer having a diameter with an arc of a decreasing curved cross section approximating said arc of said curved cross section of said open sleeve; placing said hollow retractor and said tapered tipped wedge introducer into the delicate tissue; advancing said hollow retractor and said tapered tipped wedge introducer through said delicate tissue to a surgical site therein; retracting said tapered tipped wedge introducer from said open sleeve of said hollow retractor adjacent the tissue; and, accessing at least one inflatable prosthetic member into the delicate tissue and inflating the inflatable member.
 24. An apparatus providing access to delicate tissue through a transcutaneous incision comprising: an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer; said open sleeve hollow retractor being tapered; said open sleeve hollow retractor having a decreasing elliptical cross section; said wedge introducer being tapered; said wedge introducer having a decreasing elliptical cross section; said wedge introducer being introduced into an area adjacent to said hollow sleeve; a distal tip of said wedge introducer extending beyond a distal end of said hollow retractor, at a location region forward of a distal end of said hollow retractor, so that said wedge introducer traverses the delicate tissue ahead of said distal end of the hollow retractor, guiding said hollow retractor into place to the delicate tissue; said tapered tipped wedge introducer being removable from said open sleeve of said hollow retractor adjacent the delicate tissue, leaving the delicate tissue exposed to a said open sleeve of said hollow retractor; said tapered tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve; said hollow retractor and said tapered tipped wedge introducer being insertable adjacent to the delicate tissue; said hollow retractor and said tapered tipped wedge introducer being advanced together to the delicate tissue; said hollow retractor providing access for at least one surgical instrument to a surgical site within the delicate tissue; said hollow retractor including a handle attachable to a clamp; said handle having a base where said handle is attached to said hollow retractor, said handle merging with said base in a cascading shape, interrupting the continuous curve of the proximal end of the hollow retractor, said cascading dip providing easier finger access into a working channel of said hollow retractor; and, said hollow retractor and said tapered tipped wedge introducer including a lock temporarily locking said tapered tipped wedge introducer adjacent to said hollow retractor.
 25. An apparatus providing access to delicate tissue through a transcutaneous incision comprising: an interleaved combination of an open sleeve hollow retractor and a tapered tipped wedge introducer; said open sleeve hollow retractor being tapered; said open sleeve hollow retractor being arch shaped, having a decreasing arched cross section; said wedge introducer being tapered; said wedge introducer being arch shaped, having a decreasing arch shaped cross section; said wedge introducer being introduced into an area adjacent to said hollow sleeve; a distal tip of said wedge introducer extending beyond a distal end of said hollow retractor, at a location region forward of a distal end of said hollow retractor, so that said wedge introducer traverses the delicate tissue ahead of said distal end of the hollow retractor, guiding said hollow retractor into place to the delicate tissue; said tapered tipped wedge introducer being removable from said open sleeve of said hollow retractor adjacent the delicate tissue, leaving the delicate tissue exposed to a said open sleeve of said hollow retractor; said tapered tipped wedge introducer having an exterior surface corresponding to an interior surface of said hollow sleeve; said hollow retractor and said tapered tipped wedge introducer being insertable adjacent to the delicate tissue; said hollow retractor and said tapered tipped wedge introducer being advanced together to the delicate tissue; said hollow retractor providing access for at least one surgical instrument to a surgical site within the delicate tissue; said hollow retractor including a handle attachable to a clamp; said handle having a base where said handle is attached to said hollow retractor, said handle merging with said base in a cascading shape, interrupting the continuous curve of the proximal end of the hollow retractor, said cascading dip providing easier finger access into a working channel of said hollow retractor; and, said hollow retractor and said tapered tipped wedge introducer including a lock temporarily locking said tapered tipped wedge introducer adjacent to said hollow retractor. 